ES2273729T3 - INFUSION DEVICE FOR CIRCUITS EXTERNAL TO THE ORGANISM. - Google Patents

Abstract

An infusion device for blood circuits external to the organism, comprising a tubular cylindrical body (16) having an axial channel (20) and which is intended to be inserted into a blood flow circuit in such a way that the axial channel is part of the blood flow path, a housing (24) formed by a cylindrical sleeve (22) rigidly fixed to the tubular body in such a way that the bottom surface or base (26) of the housing is tangential to the tubular body, the housing communicating ( 24) with the tubular body (16) through a radial opening (28) formed in the wall or housing of the tubular body, a partition (12) of resilient material, housed in the housing (24), and a round nut of connection and closure (14) engaged with the side walls of the sleeve-type housing in order to hold the partition (12) in position against the base surface (26) of the housing (24), the round nut (14) having an axi duct al (48), vertically aligned with the center of the radial opening (28), and having an outer end that can be connected to a unit for supplying the infusion solution and an inner mouth or end (52) open towards a space between the partition (12) and a bottom surface (54) of the round nut and communicating freely with it and in which both the partition (12) and the tubular body (16) have at least one infusion hole (38 and 30, respectively) to place the axial channel (20) of the tubular body (16) in communication with the space between the partition (12) and the bottom surface (54) of the round nut, the bottom surface of the round nut being in parallel to the base surface (26) of the sleeve-type housing and, consequently, to the partition, the mouth (52) of the axial duct (48) of the round nut (14) of the bottom surface (54) of the nut protruding round in order to lean against the partition (12) in a tight manner in the area of the radial opening (28), also, the bottom surface (54) of the round nut having a first circumferential recess (56) concentric with the mouth (52) protruding from the axial duct (48) and at least a second inlet (58) extending from the first inlet (56) to the at least one infusion port (30, 38) so that, in a condition where the infusion solution is supplied at a pressure greater than a predetermined limit in the axial conduit (48), an infusion path is defined from the axial conduit (48) of the round nut to the at least one infusion hole (38, 30).

Description

Infusion device for external circuits to the organism

The present invention relates, in general, to devices for infusion of injectable solutions through of blood or enteral pathways and, more specifically, to devices disposables of the type mentioned above associated with parenteral infusion equipment or directly to devices for external circulation to the organism.

The infusion of injectable solutions, in particular of a pharmacological nature, is a practice that It is widespread in the medical field for the treatment of various pathological processes; for example, this practice is used as nutritional support when there are pathological processes in the digestive system, in post-operative situations, for the treatment of shock states and, more generally, in all the cases in which it is necessary to enter the system circulatory drugs or substances that cannot be assimilated if They administer by other means.

Normally, the infusion is carried out introducing a needle into the selected blood vessel. The part Rear of the needle is connected to a part of plastic material flexible tubular which, in turn, is connected to the container of the solution to be infused to the patient. If the container is placed at a level above the infusion point in the patient, the solution to be injected flows by gravity and passes  to the venous circulatory system.

Normally, other devices and components that have specific functions are connected to the element tubular between the solution vessel and the infusion needle, to to know:

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a drip chamber that serves as visual check of the infusion being performed and of small reserve of the solution that is being infused,

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a flow regulator based on more or less pronounced crushing of the tubular element and that it also allows an instant interruption of the supply,

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an "infusion point" that allows you to add another solution to the infusion solution principal.

Normally, the infusion point has normally Y-shaped and comprises a cylindrical main part from which a fork or lateral part extends, being also the cylindrical side part and being able to connect its end distal or free to the vessel of the additional solution, the distal end of the cylindrical main part is connected to the main infusion needle by means of the lower tubular section and the proximal end portion of the cylindrical main element It is closed by means of a perforable diaphragm. Usually, said diaphragm is made of synthetic rubber latex or rubber natural.

When the main infusion solution is going to complement with an additional solution, the rubber diaphragm, mentioned above, it is pierced with a syringe conventional full of additional solution. When the syringe, once the additional solution is injected into the flow of the main infusion solution, the opening that created the Needle closes due to the resilience of the diaphragm rubber, so that the injection point can be reused for administration of other additional solutions or even for administer various medications to the patient without the need to undergo independent injections.

In pathological processes that need blood circulation external to the organism, as in the case of hemodialysis and coronary surgery, there is also a need for Infuse medication to a patient.

As it is known, during external circulation to the organism, a blood flow is created from the patient to the treatment apparatus (a hemodialyzer or a system of extracorporeal circulation) and back to the patient, by means of a proper set of tubes.

Also, in this case, the blood circuit usually has one or more injection points and points of Sampling that allows samples to be drawn from the circulating blood, by for example, for analytical purposes, these last points being substantially similar to infusion points except that, in In this case, the syringe is used to extract samples of blood.

However, in the external circulation to organism, tubular elements of larger diameter are used, put that the flow rates of the affected liquids are greater and, therefore therefore, the dimensions of infusion and sampling points or even its shape is changed. For example, while in the intravenous infusion the point of injection is usually Y-shaped, in the case of circuits external to the organism, a sampling point or T-shaped injection (usually known as a "point of needle "), but still requires the presence of a Diaphragm of resilient material that can be pre-drilled injection or sampling.

The "needle point" consists of a body cylindrical, usually made of biocompatible plastic material, which has an axial channel for the main blood flow when the Cylindrical body is connected to the main blood circuit. The cylindrical body has a radial projection of sleeve type in whose area is formed a radial opening in the body wall cylindrical. In turn, said opening is closed by means of a perforable partition of resilient material, preferably rubber biocompatible synthetic, the partition being held in place by middle of a round nut engaged by threading (or by another procedure such as, for example, pressure gear or ultrasonic welding) with the outer surface of the projection sleeve type.

In order to carry out the infusion or sampling, the septum surface is pierced with the needle of a syringe  whose end passes through the radial hole of the body cylindrical and placed in the main blood flow. The infussion of the solution contained in the syringe to the bloodstream main or the extraction of a measured amount of blood in the cylinder mentioned above is done by operating the  syringe plunger in a direction such as to eject the liquid contained in the syringe barrel or in a direction such as to introduce liquid into the cylinder in question.

However, in recent years the use of injection or sampling points of the type mentioned previously, that is, with the use of a syringe for Diaphragm perforation, has caused increasing problems since its use inevitably entails, for health personnel and parasanitary, the risk of puncturing by accident, exposing in this way the staff at serious risks of infections and infections,  mainly of a viral nature, which can be transmitted by blood medium

Precisely, in order to avoid such problems related to the use of syringes, have already been proposed and developed several devices that have the same objective functional, but using syringes or the like without needles.

Among these solutions there are three that are used mainly in venous lines for infusion combined with the blood sampling

The first of these solutions provides for a modification of the "needle point" device by replacement of the normal perforable septum with one that has a precut notch, so that sampling can be carried out or infusions without the help of a needle, but simply by a suitable tip of plastic material embedded in the syringe instead of the normal steel needle.

The second solution provides for the use of a key three ways comprising substantially a cylindrical housing which has three radial openings arranged in angular spaces default (usually at 90º).

A cylindrical or male valve element, housed in the cylindrical housing, it can rotate around its axis (and therefore around the housing axis cylindrical) and has three radial ducts that converge in the center and that open on the surface of the cylindrical element in angularly offset positions in the same way as openings formed in the cylindrical housing.

Normally, with 90º offset openings, two of said ducts are aligned along a single axis which matches the path of the main blood flow and the third conduit, which is arranged perpendicular to the axis of the first two, it constitutes the way for the introduction of solutions They are going to infuse.

If the cylindrical male element is turned in a angle less than 90º, the circuit can be completely closed main blood, while a 90º turn allows the third conduit, mentioned above, in fluid communication with one of the two branches of the circuit main blood

The third solution provides a combination known as a "T-piece" that is connected to the line venous in the area of the "infusion point", which has been mentioned above, or instead of it, in order to incorporate Infusion and sampling functions at the same level.

Said device consists of a "point of Conventional needle "mounted on the venous line and allowing take blood samples A meshed tubular infusion duct it has a manual clamp to stop and / or regulate the flow, above which a male or female connector of Luer closure, with the function of putting the blood circuit in communication with the intravenous infusion set. Up Luer closure connector there is a safety plug that prevents the accidental or involuntary opening of the manual clamp without having connected before the infusion line, which leads to a loss accidental blood flow.

However, with respect to the second and third solutions the results achieved seem unsatisfactory both from the point of view of security and from the point of view of view of the complexity of the operations that must be taken to out in order, which leads to a greater possibility of errors by affected personnel

For example, in the case of the three key routes, affected personnel frequently confuse Identifications of the lines put in communication, confusion which, in turn, can lead to blood loss.

In the case of the "T-piece" part tubular corresponds to a dead space in which it can stagnate blood, forming clots when the line is not being used infusion.

In addition, duplication of security elements (the plug and the clamp in the case of the T-piece) is harmful to act quickly in emergencies.

Also, previously they have been proposed devices for infusion or injection of solutions only additional, of the type with "check valves" and are substantially similar to the "needle points" that have been briefly described above, except that the opening for the penetration of the needle tip of the infusion syringe in the axial main duct (understood as intended for main blood flow) after perforation of the septum closure, instead of closing by means of a membrane provided with a hole that communicates with an ascending chamber, only closes when the pressure of the injection or infusion of the liquid that is going to enter the main blood flow has deformed what Enough membrane. Of course, such a solution can only be use for infusion operations and not to take samples of blood.

WO / A / 92/21403 describes a infusion device for introduction of food solutions  in an extracorporeal blood circuit.

A tubular cylindrical body has a channel axial for blood and a perpendicular cylindrical housing of the tubular body that communicates with the channel through an opening radial.

In the accommodation there is a body of valve that can be opened and closed by turning a connection unit meshed with the side walls of the housing.

The connection unit has an axial conduit for food solutions aligned vertically with the center of the radial opening.

Therefore, it is still advisable provide infusion and / or infusion / sampling devices, which can be used, in particular, for blood circuits external to the organism, which substantially do not have the problems and inconveniences that have been briefly mentioned above.

More generally, it seems advisable to provide infusion and / or infusion / sampling devices for circuits blood that not only do not have the problems and disadvantages that have been mentioned above, but gather all the requirements that, if possible, should satisfy those devices, requirements that are briefly summarized as continuation:

(i)

The materials with which the devices are made should be chemically and biologically non-toxic and should be totally compatible with blood. In this regard, in addition to using biocompatible plastic materials for all components of the device, in particular, for sealing components hydraulic, medical grade silicone rubbers and thermoplastic elastomers.

(ii)

He device should be suitable for sterilization by most common and generally sterilization procedures Accepted (ethylene oxide, vapor and ray irradiation beta / gamma). The use of olefin polymers (such as polyethylene and polypropylene), for external components, of polycarbonate or ABS, for components in direct contact with blood flow and with the solutions to be infused, and silicone rubber For gaskets, it is compatible with all sterilization procedures that have been mentioned previously.

(iii)

Be you should be able to easily connect components to the device specific, such as syringes with Luer cones, Luer closures and infusion lines with connectors of the same type Luer, both in male as female versions.

(iv)

He device design should be such that the turbulence and stagnation of the venous line, to exclude blood stagnation in the device and to allow the blood sampling and infusion of other liquids with flow rates high (up to approximately 600 cc / min).

(v)

He device should allow a secure closure that excludes the contamination, as well as preventing blood leaks from the circuit blood, during connection to the device and disconnection of the same and as a result of accidental operations.

(saw)

He device should be versatile in the sense that it allows both the infusion of liquids with high flow rates such as the extraction of blood samples without the use of syringes or other components that are dangerous for the affected personnel, as well as that ensure that the blood sample taken is not contaminated by previous samples and that, during sampling, there is no risk of contamination of the blood flow from which the sample.

(vii)

Finally, the devices they should be compatible with the economic factors of the industrial production, given that the disposable nature of Devices leads to considerable consumption of them.

The objectives of the present invention are substantially achieved by an infusion device for blood circuits external to the organism of the type comprising a tubular cylindrical body having an axial channel and which is intended to be inserted into a blood flow circuit in such a way that the axial channel is part of the blood flow path, a housing formed by a cylindrical sleeve rigidly fixed to the tubular body in such a way that the bottom surface or base of the housing is tangential to the tubular body, the housing communicating with the tubular body a through a radial opening formed in the wall or housing of the tubular body, a partition of resilient material housed in the housing and a round nut of connection and closure engaged with the side walls of the sleeve-like housing in order to hold the partition in position against the base surface of the housing, the round nut having a with axial duct, aligned vertically with the center of the radial opening, and having an outer end that can be connected to a unit for the supply of the infusion solution and an open mouth or inner end towards a space between the partition wall and the bottom surface of the round nut and communicating freely with it, characterized in that both the partition wall and the tubular body have at least one infusion hole to place the axial channel of the tubular body in communication with the space between the partition wall and the bottom surface of the nut round, the bottom surface of the round nut being parallel to the base surface of the sleeve type housing and, consequently, to the partition, the axial duct mouth of the round nut protruding from the bottom surface in order to rest against the partition in a sealed manner in the area of the radial opening, also, the bottom surface of the round nut having a first recess concentric circumferential with the mouth protruding from the axial duct and at least a second recess extending from the first recess to the at least one infusion hole so that, in the condition in which the infusion solution is supplied at a pressure greater than a predetermined limit, an infusion path is defined from the axial conduit of the round nut to the at least one orifice of
infusion.

How it will be better understood thanks to the following detailed description, given in relation to the drawings, with the infusion device according to the present invention can be opened communication between blood flow path and outside only when the hydraulic connection with the supply has been made external solution to be infused and the supply is being performing at a pressure higher than the internal flow pressure main blood

In addition, in the case of involuntary separation or accidental supply of the solution to be infused, the device of the invention acts as a check valve, avoiding leaks or loss of blood abroad.

Equally important is the fact that the device has a single opening position to carry out the infusion, so that human errors are not possible.

Finally, a "needle point" of suitable dimensions, of the type described above, that can be associated with a sampling syringe that works without a needle, can be associated with the cylindrical body, which has been previously mentioned.

In relation to the drawings:

Figure 1 is an axial sectional view of the version of the device of the present invention that can be used only for infusion, in the open condition to carry out the infusion;

Figure 2 is a perpendicular axial section of the device of Figure 1;

Figures 3 and 4 are similar views thereof. device in the closed condition;

Figure 5 is a plan view, from below, of the round nut of the drawings device precedents;

Figure 6 is a plan view of the partition made of resilient material used in the device of the Figures 1 to 4;

Figure 7 is a plan view, from above, of the sleeve-type cylindrical housing of the device from Figures 1 to 4;

Figures 8 and 9 are views similar to those Figures 1 and 2 of the version of the device of the invention which is Can use for infusion / sampling.

First, in relation to Figures 1 and 2, as with Figures 5, 6 and 7, they show a shape of embodiment of the version of the device of the invention which is suitable for infusion of a solution in the bloodstream that circulates in a circuit external to the organism.

The device comprises three components main, namely:

(to)

a tubular cylindrical body indicated as a unit and generally with reference number 10,

(b)

a partition 12 made of resilient material and

(C)

a round connecting and closing nut, indicated as a unit with the reference number 14.

The tubular cylindrical body 10, shown in section in Figures 1 and 2 and in plan from above in the Figure 7, comprises a conduit 16 having two connectors of end 18 for the gear of the two ends of a circuit (no shown) for the circulation of blood outside the body. He axial channel for bloodstream circulation is indicated with the number 20.

Formed in one piece with the duct tubular 16 which, as already indicated, is made of material biocompatible plastic, there is a sleeve 22 forming a housing substantially cylindrical 24 whose base wall 26 is arranged in a plane tangential to the outer surface of the duct 16.

In the center of accommodation 24, on the wall of the conduit 16, there is a radial opening 28 that puts the channel 20 in direct communication with accommodation 24.

In addition, in the area of the upper generatrix of the conduit 16, there are two holes 30A and 30B that also put the channel 20 in communication with the space above the base wall 26.

Also, accommodation 24 has, in the area of its peripheral contour, two symmetrical steps 32A and 32B and two symmetric incoming 33A and 33B that have the functions that are explain later.

The partition 12 of resilient material, such as, for example, biocompatible synthetic rubber, is housed in the housing 24 and has a circular body 34 that has two entrances curves 36A and 36B for coupling with steps 32A and 32B when partition 12 is placed against base 26 of the housing 24, in order to avoid translational or rotational movements of the partition regarding accommodation 24 and, in particular, regarding its base 26.

Two through holes, indicated with numbers 38A and 38B, are perfectly aligned axially with the holes 30A and 30B, respectively, when partition 12 is introduced in the housing 24.

Finally, in Figure 6, the part of the partition which is arranged in a centered position with respect to the opening 28 is indicated by the number 40.

Finally, in relation to the round nut of connection and centering 14, it comprises a sleeve 42 whose U-shaped section and surrounds the vertical wall 22 of the sleeve which forms the housing 24. The sleeve 42 is connected by middle of a radial wall 44 to a connector, generally indicated with the number 46. Said connector has an axial conduit 48, whose outer wall 50 has threads to allow the coupling of a conventional infusion device, for example, of the Luer type, It is not shown in the drawings.

The bottom wall of the round nut 14, which It is shown in plan in Figure 5, it has a mouth 52 that constitutes the end of the axial duct 48, the mouth protruding a predetermined distance from the plane of the adjacent base wall 54 of the round nut 14.

The base wall 54 has a first recess 56, concentric with the center of the mouth 52, and two incoming seconds 58A and 58B, arranged radially in the base wall 54 and extending from first inlet 56 to an aligned point axially with holes 30A, 30B and 38A, 38B when Assembled the device.

By turning the round nut 14 around the axis of the axial duct 48, the two can be placed incoming seconds in positions where they are aligned or not are aligned with infusion holes 38A, 38B and, therefore both, with holes 30A and 30B. Preferably, the entrees 33A and 33B are arranged in the outer wall of the housing 26 and stopper elements 43A and 43B mesh therein in order to limit the rotation of the round nut to the positions that have been mentioned above, positions shown in the Figures 1, 2 and 3, 4, respectively.

The device works as follows: with the round nut 14 arranged in the condition shown in the Figures 3, 4, in which the connection is closed, partition 12 close radial opening 28 and incoming seconds 58A and 58B not are aligned with holes 30A, 38A and 30B, 38B so that communication between axial conduit 48 and the main blood flow duct 20.

Once an infusion set is connected intravenous to the axial duct 48 of the round nut 14 the latter  it is rotated from the position of Figure 3 to that of Figure 1, of so that the incoming seconds 58A, 58B are arranged in the zone of infusion holes 30A, 38A and 30B, 38B, of course, communicating at the other end with the first entrant circumferential 56.

However, communication between said incoming seconds and axial conduit 48 is still blocked due to the fact that the mouth 52 of the axial duct 48 presses against the upper surface of the partition 12, forming, of that mode, a gasket.

When the liquid to be infused is supplies the conduit 48 with sufficient pressure to overcome the pressure in channel 20, part 40 of partition 12 disposed in the area of the opening 38 deforms, entering in the opening and in the channel 20, so that a hydraulic connection open between the mouth 52 of the axial duct 28, the first circumferential inlet 56, the two incoming seconds 58A and 58B and the corresponding pairs of infusion holes 30A, 38A and 30B, 38B, so that the solution to be infused is injected into the bloodstream that flows into channel 20.

If, for some reason, the pressure should be reduced of supply of the solution to be infused into the duct axial 48 below the limit value or, in any case, by below the bloodstream pressure, septum 12 is fold back immediately against mouth 52, interrupting the communication between the bloodstream channel and the axial conduit 48, so that there is no appreciable loss of blood, except for the really minimal amount that can infiltrate the injection holes, in seconds Starters and in the first entree.

Therefore, it is clear that the objective main invention is achieved in a simple way and sure.

Then, in relation to Figures 8 and 9, they show the embodiment of the invention that it can be used both for infusion and for the extraction of bloodstream samples circulating in channel 20.

In this embodiment, in the part right of the drawing, an identical infusion device is shown to the one shown in Figures 1 and 2.

In this embodiment, the element tubular 16 provides a second hole 60 formed in its wall between the two connectors 18, said hole being defined by means of a sleeve type element 62, likewise, preferably, formed in one piece with the element wall tubular 16 on whose outer surface a housing is formed circular 64 to accommodate a partition 66 in a position adjacent to the hole 60.

Preferably, partition 66 is made of resilient material similar to that formed by partition 12 of the infusion device and is held in place by means of a round nut 68 that has a U-shaped wall in order to surround from the outside the cylindrical wall of the sleeve 62 to which it is coupled, for example, by means of a screw thread.

Preferably, partition 66 is of the type pre-drilled that allows you to insert the end of a nozzle or tip attached to a sampling syringe.

It can be easily appreciated thanks to the Figure 8 that the combined device illustrated therein allows molding the main body constituted by the duct tubular 16, the two end connectors 18 and the two sleeves 22 and 62. At the same time, still in the molding stage, they can be preformed holes 28 and 60, as well as, in the case of the device infusion, holes 30A and 30B, steps 32A and 32B and, by Last, accommodation 33A and 33B.

Therefore, partitions 12 and 66 are produced independently, provided with holes 38A, 38B and recessed parts 36A, 36B in the case of partition 12, and with the preperforation, known per se, in the case of the partition 66.

Finally, again, the two round nuts 42 and 68 are produced independently.

The device can be assembled easily and quickly and its operation, as noted, is safe, It does not lend itself to human error and is not dangerous for personnel affected as far as the flow sampling is concerned blood

In addition, leaks are substantially eliminated or blood stagnation

In addition, they can be fulfilled and satisfied and meet and satisfy all the requirements that have been listed previously regarding devices of this type, both from the point of view of the materials that can be used as from the point of view of infusion of other liquids with flow rates elevated and blood sampling without the samples taken or the main blood flow is contaminated with samples previous.

The invention has been described in relation to preferred embodiments, but, of course, are possible and to expect modifications and conceptual variations and Structural equivalents without departing from the scope of claims.

Claims (9)

1. An infusion device for circuits blood external to the body, which comprises a body tubular cylindrical (16) that has an axial channel (20) and that is thought to insert it into a blood flow circuit of a such that the axial channel is part of the flow path blood, a housing (24) formed by a cylindrical sleeve (22) rigidly fixed to the tubular body in such a way that the lower surface or base (26) of the housing is tangential to tubular body, communicating the housing (24) with the body tubular (16) through a radial opening (28) formed in the wall or casing of the tubular body, a partition (12) of material resilient, housed in the housing (24), and a round nut of connection and closure (14) meshed with the side walls of the sleeve type housing in order to hold the partition (12) in position against the base surface (26) of the housing (24), the round nut (14) having an axial conduit (48), aligned vertically with the center of the radial opening (28), and having an outer end that can be connected to a unit for the infusion solution supply and an inner mouth or end (52) open towards a space between the partition (12) and a surface bottom (54) of the round nut and communicating freely with the same and in which both the partition (12) and the tubular body (16) have at least one infusion hole (38 and 30, respectively) to place the axial channel (20) of the tubular body (16) in communication with the space between the partition (12) and the lower surface (54) of the round nut, the lower surface of the round nut parallel to the surface base (26) of the sleeve-type housing and, consequently, to partition, protruding the mouth (52) of the axial duct (48) of the round nut (14) of the bottom surface (54) of the nut round to lean against the partition (12) in a tight way in the area of the radial opening (28), also having the bottom surface (54) of the round nut a first recess circumferential (56) concentric with the mouth (52) protruding from the axial duct (48) and at least one second inlet (58) extending from the first entrant (56) to the at least one infusion hole (30, 38) so that, in a condition in the that the infusion solution is supplied at a pressure greater than a predetermined limit in the axial duct (48), a infusion path from the axial duct (48) of the nut round to at least one infusion hole (38, 30). An infusion device for blood circuits external to the organism according to claim 1, characterized in that respective pairs of diametrically aligned holes (30A, 30B and 38A, 38B) are formed in the partition (12) and in the base surface (26) of the housing (24) and two radial incoming seconds (58A, 58B) are formed, consequently, in the base wall (54) of the round nut (14). 3. An infusion device for blood circuits external to the organism according to claim 1, characterized in that the predetermined pressure limit is greater than the pressure present in the blood flow circulating in the axial channel (20) of the tubular duct (16). An infusion device for blood circuits external to the organism according to claim 1, characterized in that two symmetrical steps are formed on the base surface (26) of the housing (24) and the partition (12) has recesses or peripheral recesses (36A , 36B) for coupling with the steps. An infusion device for blood circuits external to the organism according to claim 1, characterized in that the base surface (26) of the housing (24) has two symmetrical recesses (33A, 33B) and the base surface (54) of the round nut (14) has two stop elements (43A, 43B) to cooperate with the recesses (33A, 33B) in order to limit the angle of rotation of the round nut with respect to the sleeve-type seat between the open and closed positions of the device. An infusion device for blood circuits external to the organism according to claim 1, characterized in that the axial duct (48) of the round nut (14) has an outer surface (50) having means for provisional coupling with a device for the Infusion solution supply. An infusion / sampling device for blood circuits external to the organism, characterized in that a second cylindrical sleeve type part (62) is fixed to the housing of the tubular cylindrical body (16) of the infusion device according to claim 1, the base of the second part of the cylindrical sleeve type (62) in communication with the axial channel (20) of the tubular conduit (16) through a radial hole (60), the radial hole being defined by means of a circular housing (64 ) formed in the sleeve, the housing (64) being able to accommodate a partition (66) of resilient material, held in place by means of a round nut (68) in retaining gear with the sleeve type part (62), having the partition (66) means for the extraction of blood from the bloodstream that circulates in the axial channel (20). An infusion / sampling device for blood circuits external to the organism according to claim 7, characterized in that the partition (66) is pre-drilled to take samples by means of a nozzle or a tip attached to a syringe without a needle. 9. An infusion / sampling device for blood circuits external to the organism according to claim 7, characterized in that the retaining nut has a U-shaped side wall in order to surround the cylindrical wall of the sleeve (62) from the outside.